VELORIN Film-coated tablet (2019)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Velorin 25 mg film-coated tablets. Velorin 50 mg film-coated tablets. Velorin 100 mg film-coated tablets.

2. Qualitative and quantitative composition

Velorin 25 mg film-coated tablets Each film-coated tablet contains 25 mg atenolol. Excipient(s) with known effect: This product contains 32.5 mg lactose. Velorin 50 mg film-coated tablets Each film-coated ...

3. Pharmaceutical form

Film-coated tablet. Velorin 25 mg film-coated tablets: White, round, film-coated tablets. Velorin 50 mg film-coated tablets: White, round, film-coated tablets. Velorin 100 mg film-coated ...

4.1. Therapeutic indications

Control of hypertension. Management of angina pectoris. Control of cardiac arrhythmias. In early intervention in the acute phase of myocardial infraction and for long-term prophylaxis after recovery from ...

4.2. Posology and method of administration

Posology Adults Control of hypertension Most patients respond to 50 mg daily given orally as a single dose. If necessary, the dose may be increased to 100 mg daily. The effect will be fully established ...

4.3. Contraindications

Velorin, as with other beta-adrenoceptor blocking drugs, should not be used in patients with any of the following: hypersensitivity to the active substance, or to any of the excipients listed in section ...

4.4. Special warnings and precautions for use

Velorin, as with other beta-adrenoceptor blocking agents: although contraindicated in uncontrolled heart failure (see section 4.3) may be used in patients whose signs of heart failure have been controlled. ...

4.5. Interaction with other medicinal products and other forms of interaction

Adrenergic neurone-blocking agents Adrenergic neurone-blocking agents such as guanethidine, reserpine, diuretics and antihypertensive agents, including the vasodilator group, will have an additive effect ...

4.6. Pregnancy and lactation

Caution should be exercised when Tenormin is administered during pregnancy or to a woman who is breast-feeding. Pregnancy Velorin crosses the placental barrier and appears in the cord blood. No studies ...

4.7. Effects on ability to drive and use machines

Velorin has no or negligible influence on the ability to drive and use machines. However, it should be taken into account that occasionally dizziness or fatigue may occur.

4.8. Undesirable effects

Velorin is well tolerated. In clinical studies, the undesired events reported are usually attributable to the pharmacological actions of atenolol. Tabulated list of adverse reactions The following undesired ...

4.9. Overdose

The symptoms of overdosage may include bradycardia, hypotension, acute cardiac insufficiency and bronchospasm. General treatment should include: close supervision, treatment in an intensive care ward, ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Beta blocking agents ATC code: C07AB03 Mechanism of action Atenolol is a beta–blocker which is beta1-selective (i.e. acts preferentially on beta1-adrenergic receptors ...

5.2. Pharmacokinetic properties

Absorption Absorption of Atenolol following oral dosing is consistent but incomplete (approximately 40-50%) with peak plasma concentrations occurring 2-4 hours after dosing. The Atenolol blood levels are ...

5.3. Preclinical safety data

Atenolol is a drug on which extensive clinical experience has been obtained. Relevant information for the prescriber is provided elsewhere in the Summary of Product Characteristics.

6.1. List of excipients

Velorin 25 mg and 50 mg film-coated tablets Core: Lactose Povidone Magnesium stearate Pregelatinised starch Talc Maize starch Microcrystalline cellulose Colloidal silicon dioxide Sodium lauryl sulfate ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

5 Years.

6.4. Special precautions for storage

Store below 25°C. Protected from light and moisture.

6.5. Nature and contents of container

Velorin 25 mg film-coated tablets: PVC/Aluminium blisters. Pack-sizes of 30 and 1000 film-coated tablets. PP containers with PE closures. Pack-size of 1000 film-coated tablets. Velorin 50 mg ...

6.6. Special precautions for disposal and other handling

Not applicable.

7. Marketing authorization holder

Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

8. Marketing authorization number(s)

Velorin 25 mg film-coated tablets: 19697 Velorin 50 mg film-coated tablets: 12371 Velorin 100 mg film-coated tablets: 10379

9. Date of first authorization / renewal of the authorization

Velorin 25 mg film-coated tablets: Date of first authorization: 18 July 2005 Date of latest renewal: 03 October 2012 Velorin 50 mg film-coated tablets: Date of first authorization: 06 July ...

10. Date of revision of the text

21/08/2019

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